Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-24 @ 3:42 AM
Study NCT ID:
NCT02003534
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Set included all treated patients and was used to evaluate adverse events (AEs) and serious adverse events (SAEs).', 'eventGroups': [{'id': 'EG000', 'title': '0.15% Brimonidine Tartrate', 'description': '0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.', 'otherNumAtRisk': 372, 'otherNumAffected': 24, 'seriousNumAtRisk': 372, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctiva Hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Intraocular Pressure (IOP) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '0.15% Brimonidine Tartrate', 'description': '0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.4', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 3 (N=330)', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).', 'unitOfMeasure': 'Millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: patients with baseline data and data at the indicated time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.15% Brimonidine Tartrate', 'description': '0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '0.15% Brimonidine Tartrate', 'description': '0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '17.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '161', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '215', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2013-12-02', 'resultsFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-24', 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Intraocular Pressure (IOP) in the Study Eye', 'timeFrame': 'Baseline, Month 3', 'description': 'IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of open-angle glaucoma or ocular hypertension\n\nExclusion Criteria:\n\n* Used Alphagan® in previous 3 months'}, 'identificationModule': {'nctId': 'NCT02003534', 'acronym': 'APOTUS', 'briefTitle': 'A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'CN-BRI-1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.15% Brimonidine Tartrate', 'description': '0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.', 'interventionNames': ['Drug: 0.15% Brimonidine Tartrate']}], 'interventions': [{'name': '0.15% Brimonidine Tartrate', 'type': 'DRUG', 'otherNames': ['Alphagan® P'], 'description': '0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.', 'armGroupLabels': ['0.15% Brimonidine Tartrate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}